Alla Konson, Principal Consultant

We provide support to start-up and growing companies in the medical device industry. With a focus on the unique needs of organizations, we partner with you to design and plan implementation of a Quality System that strategically aligns your requirements and the applicable regulations and standards.

We will work to establish the required quality processes, procedures and records to ensure compliance and support of your business goals. To sustain a successful Quality System for your organization, we deliver training, provide mentoring to your personnel and facilitate ISO Certification.

We also help revamp organizations looking to update and innovate their current Quality System. We help you drive change to re-align and boost your Quality System when faced with an increased level of customer complaints, low customer satisfaction, high Cost Of Poor Quality (COPQ), low productivity, or poor supplier performance.

We will evaluate your systems and processes to close the gaps. Our services include development, documentation and implementation of a quality plan to show measurable improvements. We will also ensure your CAPA system is effective and continuously responding to trends.

We prepare your company for an FDA Inspection and guide you through the process to avoid 483's or a Warning Letter.  If needed, we help with remediation activities and correspondence with FDA.

We will prepare facilities for a successful inspection, and provide on-site assistance during the process. Our services for inspection readiness include training, review and organization of records and quality documentation to ensure timeliness of inspection. We help you prioritize and close open issues.